Lead Report Developer

Role Summary

Lead Report Developer based in Cambridge, MA. Responsible for delivering PV reporting and analytics solutions, leading BI development, and guiding global reporting standards and processes. Up to 100% remote work is allowed.

Responsibilities

• Deliver pharmacovigilance reporting and analytic solutions for Takeda Patient Safety & Pharmacovigilance (PSPV).
• Identify and develop methods for statistics and AI/Machine Learning to support data needs.
• Solve business problems in drug safety to enhance understanding of tools and techniques.
• Identify and document end-user system needs and requirements for Global Pharmacovigilance reporting.
• Provide strategic technical input into roadmaps and plans for implementing BI capabilities (reporting, interactive analysis views, dashboards).
• Lead and perform user needs and requirements analysis; support construction and maintenance of BI solutions using Oracle, Cognos, and other technologies (requirements, designs, source code development, unit testing, maintenance, migration).
• Lead tuning and optimization of global reporting solutions; mitigate risks in proposed solutions.
• Lead and execute development of global custom reports and ad hoc queries; contribute to prioritization, planning, and execution of global reports.
• Lead complex global system and data investigations supporting end-user inquiries and Global Pharmacovigilance requirements.
• Provide input into global reporting development standards, procedures, and best practices.
• Research and implement automated processes to improve efficiency in PV reporting and analytics service delivery.
• Perform audit and inspection support related to Global PV Reporting and Analytics.
• Develop, track, and report quality metrics for Global PV reports.
• Provide mentoring, training, and best practices for ad-hoc query and other global report developers.

Qualifications

• Required: Bachelor‚Äôs degree in Computer Science, Data Science, Pharmaceutical or Life Science or related field plus 5 years of related experience.
• Required: Experience with drug safety systems and their data models; design, development, documentation, testing, and deployment of custom reports, dashboards, and database views to meet requirements.
• Required: Ability to plan, manage, and implement small projects following software/system development life cycle principles.
• Required: Experience with computer systems validation related to 21 CFR Part 11 & GxP; user requirements gathering, technical specification documents, and user acceptance testing.
• Required: Ability to analyze user feedback to remediate issues with the global safety database and data.
• Preferred: Experience with BI tools (Oracle, Cognos) and global PV reporting.

Skills

• BI development and reporting
• Data analysis and data modeling
• Requirements gathering and documentation
• Quality assurance and validation
• Project planning and management
• Mentoring and training

Education

• Bachelor‚Äôs degree in Computer Science, Data Science, Pharmaceutical or Life Science or related field

Additional Requirements

• Willingness to work remotely up to 100%.